External validity in a multicenter randomized clinical trial of proximal humeral fractures: the DelPhi trial.

ABSTRACT:

Background

Randomized controlled trials (RCT) are regarded as the gold standard for effect evaluation in clinical interventions. However, RCTs may not produce relevant results to all patient groups. We aimed to assess the external validity of a multicenter RCT (DelPhi trial).

Methods

The DelPhi RCT investigated whether elderly patients with displaced proximal humeral fractures (PHFs) receiving reversed total shoulder prosthetic replacement (RTSA) gained better functional outcomes compared to open reduction and internal fixation (ORIF) using an proximal humerus locking plate (PHILOS). Eligible patients were between 65 and 85 years old with severely displaced 11-B2 or 11-C2 fractures (AO/OTA-classification, 2007). We compared baseline and follow-up data of patients for two of

SUBMITTER: Tallay E 

PROVIDER: S-EPMC8783856 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature